(80 days)
The MILAGRO Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
The MILAGRO Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer of absorbable Poly(lactide-co-glycolide) (PLA PGA) compounded with beta-Tricalcium Phosphate (beta-TCP) and is available in several sizes and varied lengths.
The provided text describes a 510(k) summary for the MILAGRO Interference Screw. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on the safety and performance of the device through non-clinical laboratory testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that "Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate devices for the proposed new intended uses." However, it does not provide a specific table of acceptance criteria or detailed reported device performance metrics (e.g., tensile strength, degradation rates, biocompatibility test results, etc.). It only mentions that the device is made from a copolymer of absorbable Poly(lactide-co-glycolide) (PLA PGA) compounded with beta-Tricalcium Phosphate (β-TCP).
Therefore, a table cannot be constructed from the provided text as the specific criteria and corresponding performance values are not detailed.
2. Sample size used for the test set and the data provenance:
The document mentions "Non-clinical laboratory testing" but does not specify the sample sizes used for these tests. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective) as it pertains to laboratory testing data, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since the testing described is "non-clinical laboratory testing" and not related to clinical image interpretation or diagnosis, the concept of "experts establishing ground truth" in the traditional sense of medical image analysis does not apply here. The document does not mention any experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As this is non-clinical laboratory testing and not a clinical study involving interpretation or diagnosis, an adjudication method for a "test set" is not relevant and is not mentioned in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or mentioned. The safety and performance were based on "non-clinical laboratory testing."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical interference screw, not an algorithm or AI. Therefore, a "standalone algorithm performance" study was not conducted.
7. The type of ground truth used:
For "non-clinical laboratory testing," the ground truth would be established by physical measurements and analytical results according to established scientific and engineering standards (e.g., material properties testing, mechanical strength testing, degradation studies, biocompatibility assays). The document does not specify the exact type of physical or chemical ground truth used beyond stating "non-clinical laboratory testing."
8. The sample size for the training set:
As this is non-clinical laboratory testing for a physical medical device, there is no concept of a "training set" as would be used in machine learning or AI.
9. How the ground truth for the training set was established:
This question is not applicable due to the reasons stated in point 8.
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Ka0830
(JUN 15 2006
SECTION 6 - 510(k) SUMMARY
Page 1 of 2
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount Drive,Raynham, MA 02767 USA |
|---|---|
| Contact Person | Ruth Forstadt, RACProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount Drive,Raynham, MA 02767 USATelephone: (508) 977-3988Facsimile: (508) 828-3750e-mail: rforstad@dpyus.jnj.com |
| Name of Medical Device | Device Regulation:Fastener, Fixation, Non-Degradable, Soft Tissue(21 CFR 888.3040)Product code: HWC and MAICommon/Usual Name: Interference ScrewProprietary Name:MILAGRO Interference Screw |
| Device Classification | In accordance with per 21 CFR 888.3040, interference screws areclassified by the FDA as Class II Medical Devices. |
| Indications for Use | The MILAGRO Interference Screw is indicated for the fixation of softtissue grafts or bone-tendon-bone grafts during cruciate ligamentreconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screwsare also indicated for: medial and lateral collateral ligament repair of theknee, proximal bicep tenodesis in the shoulder and distal biceptenodesis in the elbow. |
:
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510(k) SUMMARY
Page 2 of 2
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| Device Description | The MILAGRO Interference Screw is a cannulated, threaded, taperedfastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer ofabsorbable Poly(lactide-co-glycolide) (PLA PGA) compounded withbeta-Tricalcium Phosphate (β-TCP) and is available in several sizes andvaried lengths. |
|---|---|
| Substantial Equivalence | The MILAGRO Interference Screw is a commercially marketed devicethat was subject of K032717 (cleared March 31, 2004). When used forthe proposed indications the device is substantially equivalent to theArthrex Bio-Corkscrew Suture Anchor (K003227, cleared 1/8/2001). |
| Safety and Performance | The determination of substantial equivalence for this device was basedon a detailed device description. Non-clinical laboratory testing wasperformed demonstrating that the device is safe and can be consideredsubstantially equivalent to the predicate devices for the proposed newintended uses. |
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 15 2006
DePuy Mitek % Ms. Ruth Forstadt Project Management Lead, Regulatory Affairs 325 Paramont Drive Raynham, Massachusetts 02767
Re: K060830
Trade/Device Name: MILAGRO Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: March 24, 2006 Received: March 27, 2006
Dear Ms. Forstadt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Pari 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Ms. Ruth Forstadt
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(a)/ marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240-276-0120). Also, please note the regulation vote), proc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtained, general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free rumber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.
Sincerely yours.
Ваввае Висит
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Device Name: Milagro Interference Screw
Indications for Use:
The MILAGRO Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries af the knee. Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for medial and lateral collateral ligament repair of the knee, proximal bicep teoo to'. in the shoulder and distal bicep tenodesis in the elbow.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of
(Vize-Präsident)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.